Helsinn Healthcare SA; Withdrawal of Approval of New Drug Application for TRUSELTIQ (Infigratinib Phosphate) Capsules, 25 Milligrams and 100 Milligrams

الملخص

The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) for TRUSELTIQ (infigratinib phosphate) Capsules, 25 milligrams (mg) and 100 mg, held by Helsinn Healthcare SA, C/O Helsinn Therapeutics (U.S.), Inc. (Helsinn), 200 Wood Ave. South, Suite 100, Iselin, NJ 08830. Helsinn has voluntarily requested that FDA withdraw approval of this application and has waived its opportunity for a hearing.